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GEN-TIMOLOL OPHTHALMIC SOL. 0.25%

Posted Saturday 26 July 2008 - 07:18 AM by David Chan ( HIGH significance )

ATC Code

S01ED01

Warning

Sandoz Canada, in consultation with Health Canada, is recalling SandozĀ® Timolol Ophthalmic Solution 0.25% (DIN 02166712) and 0.5% (DIN 02166720), bottles of 5 mL, 10 mL and 15 mL (products codes 8550, 8560, 8570, 8580, 8590 and 8600) because certain bottles from different lots of these products were found to contain a higher concentration of timolol than the approved labelled specifications. By using the solution at a higher concentration, the maximum recommended dosage of 1 drop twice daily of 0.5% may be exceeded. The possible adverse effects that could be expected are the same as those with therapeutic dosage, however there is a theoretical risk for an increase in severity or frequency. Adverse reactions reported with systemic beta-adrenergic blocking agents may occur with topical administration.

Evidence

Fair

Reference

http://www.hc-sc.gc.ca/dhp-mps/medeff/advisorie...

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